Skip to main content
OpenTrials
Completed

NCT Number: NCT05742438

Effects of Dexmedetomidine/Lidocaine/Intrathecal Morphine on Cancer Metastasis Biomarker After Colorectal Surgery

This is a prospective randomized controlled trial. Investigators aimed to compare the effect of three different anesthetic adjuvants (continuous infusion of lidocaine or dexmedetomidine, intrathecal morphine injection) on the biomarker for cancer recurrence and metastasis.

Patients undergoing elective colorectal cancer surgery will be randomly allocated to three parallel arms and the biomarkers for cancer recurrence and metastasis, inflammation, and immune response will be compared. And we will compare the clinical outcomes in the three method.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Perioperative period is critical in determining the risk of postoperative metastatic disease. Surgical damage and related stress response could suppress cell-mediated immunity and facilitate malignant cell survival, motility, invasion and proliferation. Increasing evidence supported that the continuous infusion of lidocaine or dexmedetomidine, or intrathecal morphine were associated with the reduction of postoperative pain and opioid consumption and improved the quality of recovery.

Also, they were reported to decrease perioperative inflammatory responses and preserve immune response which is known to be critical in anti-metastatic process during perioperative period. However, no comparison was conducted among these anesthetic adjuvants. Thus, Investigators try to evaluate the effect on the biomarkers and clinical outcomes in the three methods.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who were scheduled for elective colorectal cancer surgery American Society of Anesthesiologists physical status of I-III

Exclusion criteria

  • Atrioventricular conduction disorder
  • Having Bradycardia (<50 bpm)
  • Severe pulmonary dysfunction in pulmonary function test
  • High risk for cardiovascular complications(expected postoperative event >5%)
  • Allergy or hypersensitivity reaction to each adjuvant.
  • History or risk factors for Malignant hyperthermia
  • Body mass index >40 kg/m2

Treatment and study plan

Lidocaine IV

Drug

Continuous intravenous infusion of lidocaine

Other names: Lidocaine

Dexmedetomidine IV

Drug

Continuous intravenous infusion of dexmedetomidine

Other names: Precedex

Intrathecal morphine

Drug

intrathecal morphine injection

Other names: Morphine

Primary outcomes

  1. MMP-9

    Time frame: 1 hour after surgery

    plasma Matrix metalloproteinase-9

Secondary outcomes

  1. MMP-9

    Time frame: at the induction of anesthesia

    plasma Matrix metalloproteinase-9, on the morning of postoperative day 1

  2. MMP-2

    Time frame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery

    plasma Matrix metalloproteinase-2

  3. IL-6

    Time frame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery

    Interleukin-6

  4. VEGF

    Time frame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery

    vascular endothelial growth factor

  5. lymphocyte subset

    Time frame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery

    CD3+CD4+ (helper T cells), CD3+CD8+ (cytotoxic T cells), CD3-CD16+CD56+ (Natural killer(NK) cells), CD3+CD16+CD56+ NK T cell, CD39+, CD73+, CD39+CD73+ expressions on CD4+ and CD8+ T cells

  6. numeric rating scale

    Time frame: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)

    Pain severity with numeric rating scale for postoperative pain, the value range (0~10), a higher score means more painful

  7. Opioid consumption

    Time frame: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)

    morphine equivalent unit of opioid consumption

  8. postoperative nausea/vomiting

    Time frame: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)

    the requirement of rescue antiemetic

  9. Time to flatus

    Time frame: within 7 days after the surgery

    from the end of surgery to the time of first flatus

  10. Hospital length of stay

    Time frame: Until the discharge (up to postoperative day 30)

    from the end of surgery to patient discharge

  11. respiratory depression

    Time frame: during the night of surgery

    pulse oximetry value < 92% or the need for reintubation.

  12. urinary retention

    Time frame: within 7 days after the surgery

    need for in-and-out catheterization or reinsertion of an indwelling urinary catheter during the hospital stay after the original urinary catheter was removed, and re-operation

  13. Headache and itching sensation

    Time frame: within 3 and 1 day after surgery, respectively

    orthostatic headache and itching sensation

  14. reoperation and readmission rate

    Time frame: within 1 month after surgery and discharge, respectively

    Reoperation was defined as any surgical procedure performed under general or regional anaesthesia for treatment of complications related to the initial operation within 30 days after surgery.

    Readmission was defined as any hospital admission occurring after discharge within 30 days from the index surgery, specifically related to postoperative complications or management associated with the initial surgical procedure.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Korea Institute of Science and Technology

Registry information

Official study title

Effect of Dexmedetomidine Infusion, Lidocaine Infusion, and Intrathecal Morphine Injection on Biomarker for Perioperative Stress and Immune Response, and Cancer Progression and Metastasis in Colorectal Cancer Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.